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Regulatorische Updates30. Aug. 2026•1 Min. Lesezeit

FDA Approves ANDA 086865 for Chlorpropamide Tablet (Discontinued)

Vom PharmaCountry-Team

The FDA granted approval (ANDA 086865) for Watson Labs' oral chlorpropamide 100 mg tablet, which is currently listed as discontinued.

The U.S. Food and Drug Administration (FDA) has issued an approval for application number ANDA 086865. The submission, made by Watson Labs, was an original (ORIG) filing and received an approval status (AP) on September 24, 1984. The approved product is an oral tablet containing chlorpropamide 100 mg. It is identified under the brand name CHLORPROPAMIDE, product number 001, and is listed with a marketing status of Discontinued. No reference drug or reference standard was cited for this ANDA.

Zusammengestellt vom PharmaCountry-Team · Quelle: FDA.gov